A cardiac pacing system includes a battery powered pulse generator and one or more leads for delivering pulses to the heart. Current pulse generators include electronic circuitry for determining the nature of an irregular rhythm, commonly referred to as arrhythmia, and for timing the delivery of a pulse for a particular purpose. The pulse generator is typically implanted into a subcutaneous pocket made in the wall of the chest. Insulated wires called leads attached to the pulse generator are routed subcutaneously from the pocket to the shoulder or neck where the leads enter a major vein, usually the subclavian vein. The leads are then routed into the site of pacing, for example, within a cardiac vein. The leads are electrically connected to the pulse generators on one end and are electrically connected to the heart on the other end. Electrodes on the leads provide the electrical connection of the lead to the heart. The leads deliver the electrical discharges from the pulse generator to the heart.
After the electrode assembly is positioned at a desired location within the heart, it is desirable to provide some method for securing the electrode assembly at that location. One approach is to use a passive device which has structure to allow for tissue growth surrounding the structure to affix the electrode assembly to the heart. Another approach is to use an active device where mechanical fixation devices are used to firmly anchor the electrodes in the heart. One type of mechanical fixation device used is a corkscrew, or a helix. During placement of the lead, the tip of the lead travels intravenously through veins and the heart. While traveling through the veins, the helix at the tip of the lead may snag or attach to the side wall of the vein, which is undesirable.
During use, the lead provides and receives critical information to and from the heart. The lead, therefore, must remain in sufficient operative condition without interference from entry of bodily fluids. To prevent entry of bodily fluids into the lead, a seal is provided. Conventional leads use O-rings or puncture seals to seal the distal end of the lead from entry of bodily fluids. The O-ring seals can be difficult to manufacture due to dimensional constraints which also affects the extension/retraction mechanism of the lead, as well as the effectiveness of the seal. Puncture seals also may increase the difficultly of using an over-the-wire lead, since the seal affects the maneuverability of the lead over the guide wire. Furthermore, the seals can increase the friction between the guide wire and the lead. The friction makes it more difficult to guide the lead over the guide wire.
Accordingly, there is a need for a lead which is sufficiently sealed from the environment. What is further needed is a seal which does not interfere with the maneuverability of the lead over the guide wire.